Medical Device Daily Senior
Doctors who want to monitor their patient's ECG and blood pressure for a 24-hour period now have an alternative option to asking their patient to wear two separate monitoring devices to record the data – Vasomedical (Westbury, New York), said it recently received FDA clearance for a device designed to do both.
The company this week reported receiving FDA 510(k) clearance to market its Vasomedical-BIOX Model 2301 Combined ECG Holter and ambulatory blood pressure monitoring recorder and software analysis system. The company received FDA clearance for its Vasomedical BIOX Model 1305 Holter monitor and anaylsis software this time last year (Medical Device Daily, April 10, 2009).
Traditionally, devices that record ECG signals and devices that monitor blood pressure are separate systems, Jun Ma, PhD, president/CEO of Vasomedical, told MDD.
Ma explained that under certain conditions, doctors sometimes prescribe both devices for the patients to wear for a 24-hour period.
“Our combined two-in-one device eliminates the need of carrying two devices, so it becomes compact and a lot more comfortable to wear,“ Ma said. He added that a second benefit of the system is that the interaction of the two signals allows the system to measure the patient's blood pressure signal at the same time as they experience certain cardiac abnormalities, which provides added diagnostic value, he said.
“These are the first in a line of Vasomedical-BIOX ECG Holter and ambulatory blood pressure monitoring systems that Vasomedical intends to bring to the marketplace,“ Ma said. “The introduction of Model 1305 Holter Monitor last year placed Vasomedical into the patient monitoring business with a high quality digital equipment that has enjoyed international success. The Model 2301, however, will make Vasomedical a supplier of ambulatory equipment, because it is so far the only combined ambulatory ECG/blood pressure recording device in the United States. In addition to being a compact device that replaces two separate recorders, it also provides interactive blood pressure recording at times of certain cardiac abnormalities, thus significantly enhancing the diagnostic value of the recorded data while increasing patient comfort and ease of use.“
Ma said the company plans to add a few more ECG devices to the product line in the future.
According to Derek Enlander, MD, a New York City internal medicine physician, the Vasomedical BIOX 2301 is the only personal combined system to simultaneously and continously record and store ECG and blood pressure data for 24 hours. “The ability to view these parameters simultaneously, side by side is unique,“ Enlander said. “It gives the physician more useful information to evaluate the patient's cardiovascular status and make appropriate clinical judgment.“
Enlander noted that for the past few years, Holter monitors and other ambulatory devices have increased in use, allowing early diagnosis and disease management not only by cardiologists but by general practitioners. “I believe this product will have a great impact on the improvement of healthcare quality and reduction of healthcare cost,“ he said.
Vasomedical primarily makes enhanced external counterpulsion (EECP) systems based on its proprietary technology. According to the company, EECP therapy is a non-invasive, outpatient therapy for the treatment of diseases of the cardiovascular system currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function, the company said. Vasomedical received a U.S. patent for the technology three years ago (MDD, Feb. 7, 2008).
BIOX Instruments (Jiangsu, China), is a strategic partner of Vasomedical. BIOX makes electrical medical instruments. Its core products include Holter recorders, ambulatory blood pressure monitors and comprehensive analysis software.
Amanda Pedersen, 229-471-4212;